Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy

This study has been terminated.
(Closed due to poor accrual and lack of feasibility to finish study per DSMB)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00429702
First received: January 31, 2007
Last updated: June 26, 2014
Last verified: June 2014
Results First Received: March 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Supportive Care
Conditions: Nausea
Vomiting
Unspecified Childhood Solid Tumor, Protocol Specific
Interventions: Drug: Decadron®
Drug: Benadryl®
Drug: Ativan®
Drug: ondansetron hydrochloride

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place at participating SunCoast CCOP Research Base affiliated CCOPs and MB-CCOP institutions. Potential subjects may be provided with a paper study brochure that included a brief study overview by study staff. No recruitment or dissemination of any study brochures or materials occured prior to each site obtaining IRB approval.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Benadryl® Ativan® Decadron® (BAD) Pump

Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.

Decadron®: Given IV

Benadryl®: Given IV

Ativan®: Given IV

ondansetron hydrochloride: Given IV

Control Arm Saline

Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.

Decadron®: Given IV

ondansetron hydrochloride: Given IV


Participant Flow:   Overall Study
    Benadryl® Ativan® Decadron® (BAD) Pump     Control Arm Saline  
STARTED     3     4  
COMPLETED     3     4  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline number of participants was determined by the number of participants that completed their Baseline Study visit.

Reporting Groups
  Description
Benadryl® Ativan® Decadron® (BAD) Pump

Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.

Decadron®: Given IV

Benadryl®: Given IV

Ativan®: Given IV

ondansetron hydrochloride: Given IV

Control Arm Saline

Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.

Decadron®: Given IV

ondansetron hydrochloride: Given IV

Total Total of all reporting groups

Baseline Measures
    Benadryl® Ativan® Decadron® (BAD) Pump     Control Arm Saline     Total  
Number of Participants  
[units: participants]
  3     4     7  
Age  
[units: participants]
     
<=18 years     2     4     6  
Between 18 and 65 years     1     0     1  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     2     3     5  
Region of Enrollment  
[units: participants]
     
United States     3     4     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy   [ Time Frame: during in-patient cycle of chemotherapy, up to 4 days ]

2.  Secondary:   Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy   [ Time Frame: 3 days of following completion of first chemotherapy cycle ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was closed prior to completing enrollment based on the recommendation by the SunCoast CCOP Research Base Data Safety Monitoring Board for a lack of feasibility and poor enrollment.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: SunCoast CCOP Research Base Lead Biostatistician
Organization: SunCoast CCOP Research Base
phone: 18009091242
e-mail: ccop@epi.usf.edu


No publications provided


Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00429702     History of Changes
Other Study ID Numbers: SCUSF 0503, SCUSF-0503, HLMCC-0503, U10CA081920
Study First Received: January 31, 2007
Results First Received: March 24, 2014
Last Updated: June 26, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board